1. Field of the Invention
This invention relates to biopsy devices and, more specifically, to devices that encapsulate a tissue specimen.
2. Description of the Related Art
The prior art discloses numerous methods for surgically removing an internal tissue specimen from a target body. Techniques and the requisite medical devices exist to remove tissue specimens of all sizes. A basic technique is to make an incision proximate to the area of the tissue specimen and excise it with a scalpel. This technique can be extremely invasive, result in trauma to proximate tissue and a maximum amount of scar tissue, and leads to additional healthy tissue being removed unnecessarily.
The prior art also discloses techniques and methods that are less invasive than excising the tissue sample with a scalpel. As disclosed in U.S. Pat. No. 5,788,709, a trocar is inserted into the target body, the target body is insufflated and the tissue specimen is severed. The tissue specimen may be a cyst, a tumor, parts of an organ, a whole organ, a diseased portion of the body, a biopsy sample, or any other specimen that is desired to be removed.
The prior art further discloses many techniques for removing the tissue specimen. Proper removal of the tissue specimen is critical. Cysts and other types of diseased tissue may spill into the surrounding tissue, resulting in inflammation and transfer of malignant cells or disease. Tumors or organs larger than the trocar need to be segmented for removal, which also may lead to inflammation and transfer of malignant cells. The segmenting of the tumors or organs is technically complicated and very time consuming. In certain methods, such as motor driven morcellators, there is a high danger of injury for the organs and blood vessels in the body. Further, morcellators render the tissue specimen unusable for certain pathologies.
Devices and techniques for removing the tissue specimen while limiting the transfer of malignant or diseased cells are also disclosed in the prior art. U.S. Pat. No. 5,037,379 discloses a surgical tissue bag for percutaneously debulking tissue. The debulking is performed by inserting the bag through an access sheath into a body cavity, inserting a surgically removed tissue mass through an open end of the bag, closing the end of the bag and pulling the closed end of the bag out of the body cavity. The end of the bag is then opened and morcellating or debulking of the tissue through the open end of the bag is performed while the remainder of the bag remains in the body cavity. The bag is made of flexible and foldable material and includes an inner layer of puncture resistant material such as nylon in either woven or solid layer form for resisting penetration by a surgical morcellating instrument. The outer layer of the bag is made of a moisture proof polymeric material.
U.S. Pat. No. 5,215,521 discloses an entrapment envelope having a means for opening and closing. The entrapment envelope is constructed of flexible, low fluid permeability materials having sufficient strength to contain morcellator entry, organ fragmentation and removal.
U.S. Pat. No. 5,337,754 discloses a tissue isolation bag which expands from a collapsed configuration to an expanded configuration when pressurized gas or liquid is supplied thereto.
U.S. Pat. No. 5,330,483 discloses a tissue reduction device which is thermally activated and is used in conjunction with a tissue isolation bag. The tissue reduction member is in an expanded condition at body temperature but shrinks to a smaller specimen reduced configuration when heated to a temperature above body temperature.
U.S. Pat. No. 5,611,803 discloses a tissue segmentation device incorporated into an isolation bag for segmenting tissue during an operation such as in laparoscopic surgery. The device includes one or more loops of high strength wire which can be mechanically reduced in loop diameter to cut tissue into smaller pieces. The wire loops can be heated electrically to aid in the cutting through hard-to-cut parts of the tissue. The wire can be of a shape memory alloy which shrinks when heated to form a smaller diameter loop.
U.S. Pat. No. 5,788,709 discloses a tissue specimen being removed with a bag having a side opening and an end opening. The bag is inserted into the abdominal cavity with the end opening of the bag remaining extracorporeal to a thread casing that extends through the abdominal wall. The tissue specimen is directed through the side opening and into the bag. The bag is reduced in size to snugly hold the tissue specimen. The tissue specimen is then segmented. The bag has positioning pins to hold the tissue specimen in place in the bag during the segmenting process. The segmented tissue specimen is removed through the end opening.
The bags disclosed in the prior art for retaining the tissue specimen and performing various procedures on the specimen have the disadvantage of requiring a relatively large sized insufflated region to perform the encapsulation.
U.S. Pat. No. 5,417,697 discloses a polyp removal device that severs and removes the polyp. The snare is an electrically conductive cauterization loop that is ejected from the end of an endoscopic assembly. A cup-shaped web member is also ejected from the endoscopic assembly end. The loop is placed over the polyp and the web member is opened up. A vacuum is applied to the web member to secure the polyp in the cup-shaped web member. Electrical current is conducted to the loop to sever the polyp from the patient, and the loop is closed. The severed polyp is held in the web member by suction and is removed from the patient. This device has the restriction of being used with polyps. Additionally, the entire polyp is not enclosed, resulting in possible contamination of tissue during the removal procedure.
U.S. Pat. No. 5,643,282 discloses a surgical instrument to remove excised tissue from an insufflated anatomic cavity through a body wall overlaying an endoscopic work space. A tissue grasping instrument attaches itself to the excised tissue and the tissue is pulled through a sleeve, or snake, which extends through the body wall. This device has numerous disadvantages, including the restriction of grasping the tissue specimen, which may result in severing portions of the tissue specimen which in turn remain in the patient to cause inflammation, spreading of disease, and contamination by malignant cells.
Further, the cited prior art does not disclose devices or techniques suitable for removing a cyst or a tumor from a region that is not insufflated while minimizing deposition of cells therefrom into the patient, such as removing a tumor from a breast.
Objects of the invention are met by a device for encapsulating a tissue specimen prior to withdrawal from a body. The device comprises a wand assembly, a sheath, and a guide assembly. The wand assembly defines an axis, an axial direction, and a radial direction. The sheath comprises a final portion that is connected to the wand assembly and a second portion. The guide assembly is connected to the sheath second portion, wherein the guide assembly is capable of positioning the sheath about at least a portion of the tissue specimen. In an aspect of the invention, the sheath is made of one piece. In another aspect of the invention, the sheath is made up of a plurality of noncontiguous segments. In a further aspect of the invention, adjacent noncontiguous segments overlap when the sheath is positioned about at least a portion of the tissue specimen.
The tissue specimen may take many shapes. In one aspect of the invention, the tissue specimen is of a generally rotational form. In further aspects of the invention, the tissue specimen is generally spherical, generally cylindrical, or generally ellipsoidal. Further, the tissue specimen may comprise a plurality of surfaces. The tissue specimen may also comprise a surface of a partial rotation. In a further aspect of the invention, the tissue specimen may be a segment of a generally rotational form. In another aspect of the invention, the tissue specimen is of a generally eccentric rotational form.
In an aspect of the invention, the guide assembly is capable of moving the sheath second portion in the axial direction. In other aspects of the invention the guide assembly is capable of moving the sheath second portion in a direction that is not the axial direction.
In an aspect of the invention where the guide assembly is capable of moving the sheath second portion in the axial direction, the sheath first portion is attached to the wand assembly. Further, the sheath extends from the first portion and terminates at the second portion. The sheath second portion defines an opening in the sheath through which the wand assembly extends. The opening has a diameter that is at least a maximum cross second of the tissue specimen in a plane that is generally normal to the wand assembly axis. In a further aspect of the invention, the tissue sample is positioned adjacent to the wand assembly and the sheath is positioned about at least a portion of the tissue specimen. In another aspect of the invention, the tissue sample is positioned about the wand assembly and the sheath is positioned about at least a portion of the tissue specimen.
In an aspect of the invention, the guide assembly comprises at least a sheath deployment member having an attachment end and a deployment end. The attachment end is attached to the sheath second portion with the sheath deployment member being arranged such that moving the sheath deployment member deployment end in the wand assembly axial direction results in the sheath deployment member guiding the second portion over the tissue specimen. Aspects of the invention may incorporate any suitable sheath deployment member including twine; cordage; filament; wire; a line; a band; a strap; a strand; and woven, braided, twisted, knit, looped, linked, metal, plastic, composite materials.
In an aspect of the invention, the wand assembly comprises a shaft having a distal end, a proximal end, a mid-section therebetween, an outside surface, and an axial hollow center. The shaft distal section comprises an orifice extending through the shaft to the hollow center. The first portion of the sheath is attached to the shaft mid-portion while the sheath second portion is proximate to the mid-portion. The sheath deployment member extends through the orifice and into the shaft hollow center. The sheath deployment member has a first portion that extends in the wand assembly axial direction from the attachment end to the shaft orifice. The sheath deployment member has a second portion that extends from the orifice, into the shaft hollow center, and terminates at the sheath deployment member deployment end. Moving the sheath deployment member deployment end in the wand assembly axial direction and away from the shaft distal end results in the sheath deployment member drawing the sheath second portion opening from the shaft mid-portion and toward the shaft distal end. In an aspect of the invention, the sheath is positioned about at least a portion of the tissue specimen with the sheath second portion being proximate to the shaft distal end. In an aspect of the invention, the tissue sample is disposed proximally to the wand assembly between the sheath first portion and the shaft distal end. The tissue sample may be disposed about the wand assembly or disposed adjacent to the wand assembly.
In another aspect of the invention, the wand assembly comprises a shaft having a distal end, a proximal end, and an outside surface. Both the sheath first portion and second portion are proximate to the shaft distal end. The sheath deployment member is generally oriented in the wand assembly axial direction and proximate to the shaft outside surface with the deployment of the sheath deployment member extending toward the shaft proximal end. In an aspect of the invention, at least a portion of the sheath is positioned in a hollow core that is at the shaft distal end. After encapsulation, the sheath is positioned over the tissue sample with the sheath second portion located distal to the shaft distal end. Additionally, the sheath deployment member extends from the sheath second portion and away from the shaft distal end. The tissue sample is disposed proximate to the wand assembly and proximally to the shaft distal end. The tissue sample may be disposed either about the wand assembly or disposed adjacent to the wand assembly.
In an additional embodiment of the invention, the sheath unfurls about the specimen in a rotational manner. The guide assembly of the device is capable of moving rotationally the sheath second portion about the tissue specimen. The axis of rotation of the sheath second portion may be parallel to the wand assembly axis. In a further aspect of the invention, the sheath second portion axis of rotation is generally co-existent with the wand assembly axis.
In a further aspect of the invention, the guide assembly comprises a wrapper assembly having a housing in which is disposed the sheath second portion and a tissue covering portion of the sheath. The wrapper assembly is capable of moving about at least a portion of the tissue specimen while depositing the sheath tissue covering portion thereon. In aspects of the invention, the sheath tissue covering portion is disposed in the housing in a rolled manner or a folded manner.
In a further aspect of the invention, the wand assembly has a shaft having a distal end, a proximal end, and a mid-point therebetween. Additionally, the wrapper assembly comprises a first end attached to the shaft distal end, a second end attached to the shaft mid-portion, with the housing extending between the wrapper assembly ends. In an aspect of the invention, the housing comprises an arch shape portion. In an aspect of the invention, the wrapper assembly first and second ends radially extend from the shaft. In a further aspect of the invention, the wrapper assembly first and second ends perpendicularly extend from the shaft, and the housing is generally straight.
In a further aspect of the invention in which the sheath is furled by an arm that rotates about the specimen. The sheath first portion extends along the shaft and generally between the wrapper assembly first end and the wrapper assembly second end. The tissue sample may be disposed adjacent to the shaft and between the shaft mid-portion and the distal end or disposed about the shaft and between the shaft mid-portion and distal end.
In an aspect of the invention in which the sheath unfurls about the specimen in a rotational manner, the guide assembly comprises an arm that is attached to the sheath second portion, the arm being capable of moving about at least a portion of the tissue specimen.
In a further aspect of the invention, the wand assembly comprises a shaft having a distal end, a proximal end, a mid-portion, and an outside surface. The arm comprises a first end attached to the shaft distal end and a second end attached to the shaft mid-portion. The sheath first portion is between the arm first end and the arm second end. In aspects of the invention, the arm may be arch shaped or the arm may have two ends that radially extend from the shaft. In a still further aspect of the invention, the arm has two ends that radially extend from the shaft to a connecting portion extending generally straight between the two ends. In a still further aspect of the invention, the arm has two ends that perpendicularly extend from the shaft. In an aspect of the invention, the sheath first portion generally extends between the arm first end and the arm second end along the arm. Further, the shaft may be hollow and the sheath first portion is disposed in the shaft. The sheath may be stored in the shaft in a rolled arrangement or in a folded arrangement in aspects of the invention. Again, the tissue sample may be disposed proximally to the wand assembly, may be disposed about the wand assembly, or may be disposed adjacent the wand assembly.
Relative to any of the aspects of the invention, the sheath may be comprised of a number of different materials. The sheath may be comprised of porous material, non-porous material, or selectively permeable material. Aspects of the invention may have a sheath that is comprised of woven material, braided material, knit material, web material, mesh material, a film material, a flexible laminate material, or of an elastic material.
In an aspect of the invention, the guide assembly is capable of positioning the sheath about substantially all the tissue specimen.
In an aspect of the invention, an actuator device is functionally connected to the encapsulating device. The actuator device is arranged to manipulate at least one of the components of the encapsulating device, the encapsulating device components comprising the wand assembly, the sheath, and the guide assembly.
In an aspect of the invention, a tissue cutting device is attached to the wand assembly and arranged such that it enlarges a passage for the encapsulated tissue specimen to travel through to exit the body. In a further aspect of the invention, the tissue cutting device comprises a cutting member with a first end that is attached to a midportion of the wand assembly and a second end that is attached to a distal end of the wand assembly. The cutting member extends radially from the wand assembly. In another aspect of the invention, the tissue cutting device comprises a cutting member that extends radially from a midportion of the wand assembly. Aspects of the invention may have the tissue cutting device, and is some aspects the cutting member or cutting member, connected to a radio frequency generator.
In an aspect of the invention, the wand assembly is rigid. In another aspect of the invention, the wand assembly is flexible. In another aspect of the invention, the wand assembly is articulatable to enable the wand assembly to be steered.
Objectives of the invention may also be met by a method of sheathing a tissue specimen comprising the steps of disposing an encapsulation device near the tissue specimen. The encapsulation device comprises a wand assembly, a sheath, and a guide assembly. The wand assembly defines an axial direction and a radial direction. The sheath comprises a first portion being connected to the wand assembly and second portion. The guide assembly is attached to the sheath second portion, wherein the guide assembly is capable of positioning the sheath about at least a portion of the tissue specimen. In another step of the method of sheathing a tissue specimen, the sheath is positioned about the tissue specimen portion by manipulating the guide assembly.
In an aspect of the invention, the disposing step comprises the step of inserting a distal end at the wand assembly through the tissue specimen. In another aspect of the invention, the disposing step comprises the step of inserting a distal end of the wand assembly adjacent to the tissue specimen. In an aspect of the invention, the positioning step comprises the step of directing the second portion over the tissue specimen in the axial direction. In another aspect of the invention, the positioning step comprises a step of directing the second portion over the tissue specimen in a rotational manner. In a further aspect of the invention, an axis of the rotational direction is parallel to the axial direction. In an aspect of the invention, the positioning step comprises a step of directing the guide assembly to move from a linear axial direction adjacent the wand assembly, through a gap extending radially and axially to an outer surface of the tissue specimen, and over a portion of the tissue specimen outer surface. In an aspect of the invention, the positioning step comprises the step of positioning the sheath about the entire tissue specimen.
In an aspect of the invention, the tissue specimen is disposed in a body. In a further aspect, the positioning the sheath step further comprises the step of drawing the second portion of the sheath through a periphery margin about the tissue specimen. In aspects of the invention, the disposing step may comprise the step of inserting the wand assembly into either an insufflated or non-insufflated region of the body.
In a further aspect of the invention, the method further comprises the step of withdrawing the wand assembly in the tissue specimen from the body after the positioning step. In a still further aspect of the invention, the withdrawing step comprises the step of enlarging a passage in the body through which the encapsulation device extends to facilitate removal of the tissue specimen from the body. In a further aspect of the invention, the enlarging the passage step comprises surgically expanding the passage. In a further aspect of the invention, the surgically expanding the passage step comprises radially extending a cutting device from the wand assembly. In an aspect of the invention, the surgically expanding the passage step comprises radially extending a cutting device from the wand assembly. In an aspect of the invention, the surgically expanding passage step comprises energizing a member of the guide assembly with a radio frequency generator and expanding the passage with the radio frequency energized guide assembly member.
In an aspect of the invention, the disposing step comprises the step of steering the wand assembly to the tissue specimen, wherein the wand assembly is articulatable.
Objectives of the invention are also met by a device for retrieving a tissue specimen from a body. The retrieving device has an axis, a distal end and an encapsulation assembly. The distal end is adapted for entering the body. The encapsulation assembly at least partially covers the tissue specimen prior to retrieving the tissue specimen from the body. In an aspect of the invention, the encapsulation assembly comprises an axially disposed band that is actuatable in a radial direction.
In another aspect of the invention, the encapsulation assembly comprises a plurality of bands disposed along the device axis, the bands being actuatable in a radial direction. In a further aspect of the invention, the bands have a distal end and a proximal end. The band distal ends are attached to a distal end of the retrieving device. The band proximal ends are attached to a midportion of the retrieving device. The retrieving device distal end is rotatable about the axis compared to the retrieving device midportion in order that the bands may be twisted about the tissue specimen. In an aspect of the invention, a flexible sheet spans between at least two of the bands. In a further aspect of the invention, the flexible sheet is a web.
Other and further objects and advantages will appear hereinafter.